CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy

NCT02693080 | Completed Phase 1 DMC FDA Drug FDA Device

• 3 other identifiers: IRB-31971NCI-2016-00091LUN0072
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.

Conditions

Malignant Lung Neoplasm; Metastatic Malignant Neoplasm in the Lung; Non-Small Cell Lung Carcinoma; Stage IV Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants able to complete perfusion scan acquisition at the time of treatment-planning

  Up to approximately 90 seconds

• Number of participants able to complete perfusion scan acquisition within 48 hours of SABR

  Within 48 hours post-SABR

• Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR

  Up to 4 months post-SABR

Secondary Outcomes (4)

• The calculated variance of blood flow such that measurable changes can be identified in future studies

  Baseline to up to 4 months post-SABR

• The calculated variance of blood volume such that measurable changes can be identified in future studies

  Baseline to up to 4 months post-SABR

• The calculated variance of mean transit time such that measurable changes can be identified in future studies

  Baseline to up to 4 months post-SABR

• The calculated variance of permeability such that measurable changes can be identified in future studies

  Baseline to up to 4 months post-SABR

Study Arms (1)

Diagnostic (CT perfusion imaging)

EXPERIMENTAL

Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent

Device: CAPP-Seq; Drug: Isovue-200; Radiation: Computed Tomography Perfusion Imaging

Interventions

CAPP-Seq DEVICE

Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) is an assay which allows quantitative assessment of the levels of circulating-tumor DNA in the blood sample.

Also known as: Cancer Personalized Profiling by Deep Sequencing

Diagnostic (CT perfusion imaging)

Isovue-200 DRUG

Contrast agent

Also known as: Lopamidol

Diagnostic (CT perfusion imaging)

Computed Tomography Perfusion Imaging RADIATION

Also known as: CT Perfusion Imaging

Diagnostic (CT perfusion imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases

You may not qualify if:

• Patients who are pregnant or are trying to become pregnant are excluded from this study
• Patients with renal failure, defined as glomerular filtration rate (GFR) \< 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Iopamidol; Iothalamic Acid; Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Maximilian Diehn

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 26, 2016
• Study Start: January 19, 2016
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

US (1)